Why is a BTK inhibitor important for mantle cell lymphoma (MCL) treatment?

MCL is caused by rapid growth and spread of cancerous B cells.

Bruton's tyrosine kinase (BTK) is a protein that signals to cancerous B cells, helping them to grow and spread

Blocking BTK can help stop this signaling

Treatment that is complete and consistent.

How well doesBRUKINSA work?

In 2 clinical studies, 118 patients with MCL received BRUKINSA after at least 1 prior therapy. In both clinical studies,

In 2 clinical studies, 118 patients with MCL received BRUKINSA after at least 1 prior therapy. In both clinical studies,

84 %

responded totreatment, knownas the overallresponse rate

responded totreatment, knownas the overallresponse rate

nearly

80 %

continued torespond for ayear or longer

The effectiveness of BRUKINSA may vary for different people.

The effectivenessof BRUKINSAmay vary fordifferent people.

What are the possible side effects of BRUKINSA?

BRUKINSA may cause serious side effects, including:

Bleeding problems (hemorrhage) that can be serious and may lead to death. Your risk of bleeding may increase if you are also taking a blood thinner medicine. Tell your healthcare provider if you have any signs or symptoms of bleeding, including:

blood in your stools or black stools (looks like tar)

pink or brown urine

unexpected bleeding, or bleeding that is severe or you cannot control

vomit blood or vomit that looks like coffee grounds

cough up blood or blood clots

increased bruising

dizziness

weakness

confusion

changes in your speech

headache that lasts a long time

Infections that can be seriousand may lead to death. Tell your healthcare provider right awayif you have fever, chills, or flu-like symptoms.

Decrease in blood cell counts. Decreased blood counts (white blood cells, platelets, and red blood cells) are common with BRUKINSA, but can also be severe. Your healthcare provider should do blood tests during treatment with BRUKINSA to check your blood counts.

Second primary cancers. New cancers have happened in people during treatment with BRUKINSA, including cancers of the skin. Use sun protection when you are outside in sunlight.

Heart rhythm problems (atrial fibrillation and atrial flutter). Tell your healthcare provider if you have any of the following signs or symptoms:

your heartbeat is fast or irregular

feel lightheaded or dizzy

pass out (faint)

shortness of breath

chest discomfort

What are the most common side effects?

The following side effects occurred in 20% or more of patients taking BRUKINSA:

Decreased white blood cells

Decreased platelet count

Rash

Diarrhea

Upper respiratory infection

Decreased red blood cells (anemia)

Bruising

Cough

What are the most common side effects?

The following side effects occurred in 20% or more of patients taking BRUKINSA:

Decreased white blood cells

Decreased platelet count

Rash

Diarrhea

Upper respiratory infection

Decreased red blood cells (anemia)

Bruising

Cough

7% of patients discontinued treatment due to side effects in the trials.

These are not all the possible side effects of BRUKINSA. Call your doctor for medical advice about side effects. You may report side effects to the FDA at
1-800-FDA-1088.

7% of patients discontinued treatment due to side effects in the trials.

These are not all the possible side effects of BRUKINSA. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

How long will I be on treatment with BRUKINSA?

You will take BRUKINSA for as long as your doctor thinks it is helping you, or for as long as side effects are manageable.

About 18 months was the median duration of treatment for patients in the clinical studies. The median marks the midpoint where half of the patients were still taking BRUKINSA, while half were no longer on treatment.

Remember, everyone responds differently to treatment, so the length of time that you take BRUKINSA could be shorter or longer.

How long will I be on treatment with BRUKINSA?

You will take BRUKINSA for as long as your doctor thinks it is helping you, or for as long as side effects are manageable.

About 18 months was the median duration of treatment for patients in the clinical studies. The median marks the midpoint where half of the patients were still taking BRUKINSA, while half were no longer on treatment.

Remember, everyone responds differently to treatment, so the length of time that you take BRUKINSA could be shorter or longer.

Before taking BRUKINSA, tell your healthcare provider about all of your medical conditions, including if you:

have bleeding problems

have had recent surgery or plan to have surgery. Your healthcare provider may stop BRUKINSA for any planned medical, surgical, or dental procedure.

have an infection

have or had heart rhythm problems

have high blood pressure

have liver problems, including a history of
hepatitis B (HBV) infection.

are pregnant or plan to become pregnant. BRUKINSA can harm your unborn baby. If you are able to become pregnant, your healthcare provider may do a pregnancy test before starting treatment with BRUKINSA.

Females should not become pregnant during treatment and at least 1 week after the last dose of BRUKINSA. You should use effective birth control (contraception) during treatment and for at least 1 week after the last dose of BRUKINSA.

Males should avoid getting female partners pregnant during treatment and for at least 1 week after the last dose of BRUKINSA.

are breastfeeding or plan to breastfeed. It is not known if BRUKINSA passes into your breast milk. Do not breastfeed during treatment with BRUKINSA and for at least 2 weeks after your last dose of BRUKINSA.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Taking BRUKINSA with certain other medications may affect how it works and can cause side effects.

What are the possible side effects of BRUKINSA?

BRUKINSA may cause serious side effects, including:

Bleeding problems (hemorrhage) that can be serious and may lead to death. Your risk of bleeding may increase if you are also taking a blood thinner medicine. Tell your healthcare provider if you have any signs or symptoms of bleeding, including:

blood in your stools or black stools (looks like tar)

pink or brown urine

unexpected bleeding, or bleeding that is severe or you cannot control

vomit blood or vomit that looks like coffee grounds

cough up blood or blood clots

increased bruising

dizziness

weakness

confusion

changes in your speech

headache that lasts a long time

Infections that can be serious and may lead to death. Tell your healthcare provider right away if you have fever, chills, or flu-like symptoms.

Decrease in blood cell counts. Decreased blood counts (white blood cells, platelets, and red blood cells) are common with BRUKINSA, but can also be severe. Your healthcare provider should do blood tests during treatment with BRUKINSA to check your blood counts.

Second primary cancers. New cancers have happened in people during treatment with BRUKINSA, including cancers of the skin. Use sun protection when you are outside in sunlight.

Heart rhythm problems (atrial fibrillation and atrial flutter). Tell your healthcare provider if you have any of the following signs or symptoms:

your heartbeat is fast or irregular

feel lightheaded or dizzy

pass out (faint)

shortness of breath

chest discomfort

The most common side effects of BRUKINSA include:

decreased white blood cells

decreased platelet count

rash

diarrhea

upper respiratory infection

decreased red blood cells (anemia)

bruising

cough

These are not all the possible side effects of BRUKINSA. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

What is BRUKINSA?

BRUKINSA is a prescription medicine used to treat adults with mantle cell lymphoma (MCL) who have received at least one prior treatment for their cancer.